Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT06088550
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-16', 'studyFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a change from baseline of muscle quantity', 'timeFrame': '28 days', 'description': 'assessed by ultrasound quadriceps muscle thickness'}, {'measure': 'a change from baseline of muscle strength', 'timeFrame': '28 days', 'description': 'assessed by handgrip strength'}, {'measure': 'a change from baseline of muscle performance', 'timeFrame': '28 days', 'description': 'assessed by the short physical performance battery test (SPPB)'}, {'measure': 'a change from baseline of muscle quality', 'timeFrame': '28 days', 'description': 'assessed by ultrasound quadriceps muscle echo intensity'}], 'secondaryOutcomes': [{'measure': 'a change from the baseline of nutritional status', 'timeFrame': '28 days', 'description': 'assessed by 7-point Subjective Global Assessment (SGA) score'}, {'measure': 'a change from the baseline of MELD score', 'timeFrame': '28 days', 'description': 'assessed by calculating MELD score at baseline and after 28 days'}, {'measure': 'a change from the baseline of ascites', 'timeFrame': '28 days', 'description': 'assessed by subjective clinical grading'}, {'measure': 'a change from the baseline of hematological parameters', 'timeFrame': '28 days', 'description': 'assessed by CBC'}, {'measure': 'a change from the baseline of liver enzymes', 'timeFrame': '28 days', 'description': 'assessed by laboratory assessment of liver enzymes'}, {'measure': 'a change from the baseline of BP', 'timeFrame': '28 days', 'description': 'assessed by measuring BP'}, {'measure': 'a change from the baseline edema', 'timeFrame': '28 days', 'description': 'assessed by clinical grading'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Atrophy']}, 'referencesModule': {'references': [{'pmid': '38777422', 'type': 'DERIVED', 'citation': 'Sobhy E, Kamal MM, Saad Y, Saleh DA, Elgohary R, Hassan MS. Effect of branched-chain amino acid supplementation and exercise on quadriceps muscle quantity and quality in patients with cirrhosis as assessed by ultrasonography: A randomized controlled trial. Clin Nutr ESPEN. 2024 Jun;61:108-118. doi: 10.1016/j.clnesp.2024.03.011. Epub 2024 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Ultrasound can be used to monitor muscle mass during interventional approaches in patients with liver cirrhosis.\n\nThe aim: To investigate the effect of branched-chain amino acid (BCAA) supplementation and/or muscle exercise on ultrasound-measured quadriceps muscle thickness and echo intensity, as well as on muscle strength, performance, and nutritional assessment in patients with cirrhosis.\n\nPatients \\& Methods: This is a randomized controlled study that included 220 liver cirrhosis patients with Child-Pugh B \\& C classes. They were randomized into a control group comprising 55 patients who received only the standard care, and interventional groups comprising 165 patients equally distributed into three groups, they received in addition to standard care, BCAA, programmed exercise, or BCAA and programmed exercise respectively. At baseline and after 28 days, all participants were subjected to ultrasound-measured quadriceps muscle thickness and echo intensity, in addition to handgrip strength, short physical performance battery (SPPB), anthropometric measures, hematological and biochemical assessment, MELD score measurement, nutritional assessment using 7- subjective global assessment score (SGA).', 'detailedDescription': 'This is an open, 4-arm parallel, randomized controlled trial conducted on cirrhotic patients\n\nAll eligible patients received instructions of standard care that includes standard diet and non-exercise activity thermogenesis (NEAT), then the patients were randomly assigned in an allocation ratio of approximately 1:1:1:1; group 1= control received the standard care only, and three intervention groups; group 2 received added 10 gm/day branched-chain amino acid (BCAA) (manufactured by Dulex lab company). Group 3 received added home-based exercise comprising both aerobic and resistance exercises, and finally, group 4 received added both BCAA and home-based exercise.\n\nAll patients were subjected to the following at the baseline and after 28 days:\n\n1. thorough medical history\n2. Complete clinical examination including BP, middle upper arm circumference (MUC), and body mass index (BMI) using the dry weight.\n3. The nutritional status assessment using the 7-point Subjective Global Assessment (SGA) score,\n4. Assessment of their physical fitness using the short physical performance battery test (SPPB) score.\n5. Assessment of muscle strength using handgrip strength using a digital dynamometer (Model: 12-0286).\n6. Routine labs including complete blood count (CBC), liver function, kidney function, and electrolytes, FBG\n7. Calculation of Child-Pugh \\& MELD scores.\n8. Ultrasound assessment of quadriceps muscle thickness and echogenicity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cirrhotic patients with moderate and marked liver impairment\n\nExclusion Criteria:\n\n* cirrhotic patients with Child-Pugh class A, patients with acute liver cell failure or malignancies, associated other end-organ failure, and vitally unstable patients.'}, 'identificationModule': {'nctId': 'NCT06088550', 'briefTitle': 'Effect of Branched-chain Amino Acid Supplementation and Exercise on Muscle Quantity and Quality in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Branched-chain Amino Acid Supplementation and Exercise on Quadriceps Muscle Quantity and Quality in Patients With Cirrhosis as Assessed by Ultrasonography', 'orgStudyIdInfo': {'id': 'MD-173-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group-1', 'description': 'received standard care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-2', 'description': 'received BCAA', 'interventionNames': ['Dietary Supplement: BCAA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-3', 'description': 'Recieved Exercice', 'interventionNames': ['Other: home-based graded exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-4', 'description': 'Received a combined BCAA + Exercise', 'interventionNames': ['Dietary Supplement: BCAA', 'Other: home-based graded exercise program']}], 'interventions': [{'name': 'BCAA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a branched-chain amino acid (BCAA) formula: taken by oral route in the form of 2 scoops of Protofit BCAA daily on 200 cc water, (manufactured by Dulex lab company). Each scoop contains 5 gm BCAA (2.5 gm leucine, 1.25 gm isoleucine \\& 1.25 gm valine).', 'armGroupLabels': ['Group-2', 'Group-4']}, {'name': 'home-based graded exercise program', 'type': 'OTHER', 'description': "home-based graded exercise program comprises both aerobic and resistance exercise. The exercise was done by the patients themselves aided by a physiotherapist, a nurse or patients' relatives", 'armGroupLabels': ['Group-3', 'Group-4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12346', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Aliny School of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Elham Sobhy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Rasmia Elgohary', 'investigatorAffiliation': 'Cairo University'}}}}